ALIVAL
Principal investigator:
Funding:
- Manufacturer (Les Laboratoires Serviers) as part of the safety plan imposed by EMA
Current status:
Completed in 2018. The PASS report was submitted to EMA. The validation results have been published.
ALIVAL
Validity of Hospital ICD-10-GM Codes to Identify Acute Liver Injury (ALIVAL)
Description:
This validation study took place within the framework of a multicenter EMA conditional pharmacovigilance study (Past Authorization Safety Study (PASS): Liver Toxicity of Agomelatine), in which our cooperation partner at BIPS (Bremen) is participating. The study was accepted with the specific aim to test and further develop structures and procedures of our support center from epidemiology, biometry and medical informatics.
Our results will allow the use of routine data in the context of this and other pharmacoepidemiological studies of drug safety. Liver toxicity is one of the most important drug side effects of all, which needs to be studied in multicenter databases due to its rarity, but at the same time is particularly difficult to track on routine data. The validation study will allow a better assessment of possible biases.
Publications:
- Timmer A, de Sordi D, Kappen S, Kohse KP, Schink T, Perez-Gutthann S, Jacquot E, Deltour N, Pladevall M. Validity of Hospital ICD-10-GM Codes to Identify Acute Liver Injury in Germany. Pharmacoepidemiology and Drug Safety (angenommen, Juni)
- Pladevall M, Pottegård A, Schink T, Reutfors J, Morros R, Poblador-Plou B, Timmer A, Forns J, Hellfritzsch M, Reinders T, Hägg D, Giner-Soriano M, Prados-Torres A, Cainzos-Achirica M, Hallas J, Brandt L, Cortés J, Aguado J, Perlemuter G, Falissard B, Castellsagué J, Jacquot E, Deltour N, Perez-Gutthann S. Risk of Acute Liver Injury in Agomelatine and Other Antidepressant Users in Four European Countries: A Cohort and Nested Case-Control Study Using Automated Health Data Sources. CNS Drugs 2019, 33(4), 383-395.
Conference contributions (selection):
- Pladevall M, Pottegård A, Schink T, Reutfors J, Morros R, Poblador-Plou B, Timmer A, Forns J, Hellfitzsch M, Reinders TK, Hägg D, Giner-Soriano M, Prados-Torres A, Cainzos-Achirica M, Hallas J, Kollhorst B, Brandt L, Cortés J, Aguado J, Perlemuter G, Falissard B, Castellsagué J, Jacquot E, Deltour N, Perez-Gutthann S. Agomelatine and Other Antidepressants and the Risk of Acute Liver Injury, a Post-Authorisation Safety Study in 4 European Countries. 31st European College of Neuropsychopharmacology (ECNP 2018), Barcelona; October 6-9, 2018
- Timmer A, Kappen S, de Sordi D, Pladevall M, Perez-Gutthann S, Jacqout E, Deltour N, Schink T. Validity of Hospital ICD-10-GM Codes to Identify Acute Liver Injury. 34th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE 2018), Prag; August 22-26, 2018